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Bristol-Meyers Squibb, Co.

Senior Manager, Pharmacovigilance Compliance (R1553810-en-us)

Pharmaceuticals

All

Yearly

No

Princeton, New Jersey, United States

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Functional Area Description

The WorldWide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines: The WWPS group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

Position Summary

Maintain a standard of quality and compliance with existing global regulations, compliance requirements and internal policies and procedures. Assure compliance with proper regulations and continuous improvement mechanism of trending of corrective and preventative actions.

Position Responsibilities

  • Assists management in the collection and assessment of global submission metrics of Individual Case Safety Reports (ICSRs) and Safety Aggregate Reports (SARs) to assure compliance with proper regulations and continuous improvement mechanism of trending of corrective and preventative actions.

  • Conducts thorough and careful analysis of ICSR global compliance for trending/tracking of root causes to assess global compliance risks.

  • Responsible for global Safety Aggregate Report (SAR) metric collation and distribution.

  • Partners with the PV Compliance and Quality Risk Management organization to proactively identify opportunities for process improvement to increase the effectiveness and efficiency of the WWPS organization.

  • Ensure adequate and timely escalation of incidents/issues and/or potential deviations. Lead formal investigations of issue as they arise, ensuring timely escalation to line management if critical observations or critical issues are not resolved.

  • Provide guidance during the development and execution of corrective and preventive actions (CAPA) relating the submission issues. Coordinate and review CAPAs to ensure adequate root cause analysis and systemic solutions.

  • In collaboration with WWPS stakeholders innovate processes associated with the timely submission processes. Ensure continued inspection readiness in area of expertise.

  • Assists with departmental audits and inspections (health authority, internal and co-marketing/development partner), including developing responses to audit observations and oversight of corresponding action plans.

Degree / Experience Requirements

  • A Bachelor's Degree in life sciences is required. Advanced scientific degree preferred (Masters, PharmD, BSN, RN, etc.). Strong scientific background in a life science related field (post graduate training or equivalent experience training preferred).

  • A minimum of five years pharmaceutical industry experience, and with a minimum of three years in pharmacovigilance, drug development, clinical development or regulatory affairs.

  • Knowledge of worldwide regulations pertaining to pharmacovigilance and Bristol-Myers Squibb policies and procedures is preferred. Successful and creative negotiation of difficult compliance issues.

  • Demonstrated ability to work in a complex, changing environment and be accountable for actions and results.

Key Competency Requirements

  • Advocates the highest standards of quality and compliance.

  • Ability to communicate effectively with stakeholders to identify risks and evaluate mitigations

  • Maintain a quality mindset identifying and appropriately escalating areas of risk

  • Maintains awareness of evolving regulatory and company compliance requirements including directives, policies and procedures related to Global Pharmacovigilance activities.

  • Demonstrates ability to analyze and interpret complex regulations to determine impact on company operations and policies and in developing action plans to optimize compliance.

  • Demonstrates ability to utilize Microsoft Office Suite, Corporate Safety Database, document management system for authoring, reviewing and approving electronic documentation (i.e., SharePoint, PDHQ, etc.), corporate learning management system, etc.

Travel Required

Approximately 5-10% travel may be needed, including other BMS sites, or business partners/CROs to conduct various quality or inspection related activities; attend professional meetings and seminars.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.